Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Glimepiride; Drug: Metformin; Drug: Insulin Glargine

• Registration Number: NCT00708578
• Lead Sponsor: Sanofi

Brief Summary

Primary objective:

To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level

Secondary objective:

To compare the incidence of hypoglycemia in each treatment group

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-07-02
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Type 2 diabetes for at least 6 months
• Treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other SU) for at least 3 months prior to the screening visit
• 7.0 < HbA1c < 11 %
• Fasting serum C-peptide > 0.33 nmol/L
• BMI < 30 kg/m²
• Patients who is willing to monitor BG using SMBG

Exclusion Criteria

• Type 1 Diabetes
• Clinical evidence of active liver disease, or serum ALT 3 times the upper limit of the normal range
• Serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females
• Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
• History of alcohol or other substance abuse
• Pregnancy or not using contraceptive in childbearing aged women
• Breast feeding women
• History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
• Treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Glimepiride	Administration of 4 mg of Glimepiride with Insulin Glargine
1	Insulin Glargine	Administration of 4 mg of Glimepiride with Insulin Glargine
2	Metformin	Administration of 1500 mg of Metformin with Insulin Glargine
2	Insulin Glargine	Administration of 1500 mg of Metformin with Insulin Glargine
3	Metformin	Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine
3	Glimepiride	Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine
3	Insulin Glargine	Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine

Primary Outcome Measures

Name	Time	Method
HbA1c values	At baseline to end of treatment

Secondary Outcome Measures

Name	Time	Method
Hypoglycemia events	From inclusion to end of study
Percentage of patients with HbA1c < 7%	At the end of the study
Fasting Blood Glucose level	At the end of the study

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇰🇷 Seoul, Korea, Republic of